"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
A trial of selumetinib and docetaxel for non small cell lung cancer (SELECT-1)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at selumetinib and docetaxel for non small cell lung cancer (NSCLC) that has spread into surrounding tissues (locally advanced) or has spread to another part of the body (advanced).
People with locally advanced or advanced NSCLC usually have treatment with chemotherapy. One of the chemotherapy drugs is docetaxel. People have this with other chemotherapy drugs, or on its own. But lung cancer is difficult to treat and it can continue to grow despite this treatment.
Selumetinib is a type of biological therapy. It works by targeting a
The researchers think that combining selumetinib with docetaxel may improve treatment. They also think that this may work better in people who have a particular change (mutation) to a gene called K-RAS.
This trial will compare one group of patients who have docetaxel and selumetinib with another group of patients who have docetaxel and a dummy drug (placebo).
The aims of the trial are to
- Find out if docetaxel and selumetinib work better than docetaxel alone
- Compare the side effects of each treatment
Who can enter
You may be able to join this trial if all of the following apply.
- You have non small cell lung cancer (NSCLC) that is locally advanced (stage 3B) or has spread to another part of your body (stage 4)
- Your cancer has come back or grown despite 1 other treatment for your NSCLC. If this treatment was chemotherapy before or after surgery for an earlier stage of cancer, your cancer must have come back within 6 months of this treatment
- You have a particular change (mutation) to a gene called K-RAS (the trial team will test your cancer for this to see if you can take part)
- You have at least one area of cancer that has not been treated with radiotherapy, measures at least 10mm across if it is a
lymph nodeand can be seen on a scan
- You are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
- You have satisfactory blood test results
- You are willing to use reliable contraception during treatment and for 1 month afterwards if there is any chance that you or your partner could become pregnant
You cannot join this trial/study if any of these apply. You
- Have had more than one type of treatment for NSCLC
- Have already had treatment with a drug that is a MEK inhibitor (you can check this with your doctor)
- Have have already had treatment with docetaxel
- Have had chemotherapy in the last 4 weeks. For some chemotherapy drugs this needs to be 6 weeks (the trial team can tell you more about this)
- Have had radiotherapy in the last 4 weeks, or radiotherapy for symptom control in the last week
- Have had major surgery in the last month
- Have treatment in a drug trial in the last month, or earlier if there is any chance there is still some of the drug in your body
- Are unable to have docetaxel or a drug called G-CSF for medical reasons
- Are allergic to the drugs used in this trial, anything they contain, or to similar drugs
- Have cancer that has spread to your brain or is pressing on your spinal cord (spinal cord compression) and this hasn’t been treated or is causing symptoms. You can take part if you have had treatment, it is not getting worse and you have not had steroids or drugs to prevent fits in the last month
- Have lung cancer that is a mixture of non small cell or small cell lung cancer
- Have certain heart problems (the trial team can advise you about this)
- Have certain eye conditions (the trial team can tell you more about this)
- Are known to be HIV, hepatitis B or hepatitis C positive
- Have any other medical condition that the trial doctor thinks could affect your taking part
- Have had any other cancer in the last 5 years apart from carcinoma in situ of the cervix or non melanoma skin cancer that was successfully treated
- Are still having side effects from any anti cancer treatment, apart from hair loss and tiredness (fatigue)
This is an international phase 3 trial. The researchers need about 634 people to join the trial.
It is a randomised trial. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. And neither of you will know which group you are in. This is called a double blind trial.
- People in one group have docetaxel and selumetinib
- People in the other group have docetaxel and a dummy drug (placebo)
You have docetaxel through a drip into a vein. This takes about an hour and you have it every 3 weeks. You also have G-CSF about 1 day after each dose of chemotherapy. This is an injection just under your skin (subcutaneous). It helps to increase the number of white blood cells in your body, which reduces the risk of you getting an infection.
You have selumetinib or the dummy drug as 3 tablets, twice a day. You must not eat or drink anything (except water) for 2 hours before and 1 hour after taking the tablets.
You have treatment for at least 4½ months as long as you don't have any serious side effects. After this time, you may continue treatment if your doctor thinks it would help you.
The trial team will ask you to fill out a questionnaire
- Before you start treatment
- Every week for the first 3 weeks
- Then every 3 weeks during treatment
- A month after you finish treatment.
The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.
You will see the doctors and have some tests before you start treatment. The tests include
- Blood tests
- Physical examination
- Heart trace (
- Heart scan (
echocardiogram) or MUGA scan
- CT scan, MRI scan or X-ray to measure the size of your cancer
- Bone scan if you have cancer in your bones
- Eye examination
If you have had any of these tests in the last month, you may not need to have them again before you start treatment in this trial.
The trial team will ask your doctor for a sample of your cancer that was removed when you had surgery or a biopsy in the past. They use this sample to test your cancer to see if it has a change (mutation) in the K-RAS gene. If you do not have a stored sample of cancer that can be tested, your trial team will ask to take a
If any of the sample is left after testing, the researchers will ask you if this can be used for further research in the future.
You go to hospital every week for the first 3 weeks, then every 3 weeks during treatment and at the end of treatment. You see a doctor, have blood tests and you may have some of the above tests again at some of these visits. You have a scan or X-ray every 6 weeks during treatment.
After you finish treatment you go to hospital about 1 month later. You see a doctor who may arrange some tests if they think you need them.
A trial doctor or nurse will then telephone you every 2 months to find out how you are and to ask about any new cancer medicine that you may be having.
Selumetinib is quite a new drug and there might be side effects we don't know about yet. The most common side effects include
- Feeling or being sick
- Shortness of breath
- Blurred vision
- Possible swelling of the face, legs and feet while taking selumetinib
- Tiredness (fatigue)
- High blood pressure
- Sore mouth
You are more sensitive to sunlight with this drug. So while you are having treatment, you can’t spend too long in the sun, and must cover up and use sunscreen on exposed areas.
The most common side effects of docetaxel are
- A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
- Tiredness (fatigue)
- Hair loss
- Swelling of the hands and feet due to build up of fluid in the body
- Soreness and redness of the palms of hands and soles of the feet (palmar-plantar syndrome) causing numbness and tingling
- Skin rash which may be itchy
- Discoloured finger nails
- Sore mouth
- Numbness and tingling in your hands and feet (peripheral neuropathy)
- An allergic reaction while you are having the infusion. Your nurse will monitor you closely
- Watery eyes
If you have docetaxel and selumetinib some of the side effects may be worse. You may have more problems with diarrhoea, feeling or being sick, sore mouth and you are more likely to have dry skin.
Having docetaxel and selumetinib together is also more likely to cause a drop in white blood cells, leading to infection. However, you have a growth factor called G-CSF to try and prevent this from happening.
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Fiona Blackhall
NIHR Clinical Research Network: Cancer